Open Wrench ARIEOW360

GUDID 08809931183798

ARi ExCon Implant System

Megagen Implant Co. Ltd

Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable
Primary Device ID08809931183798
NIH Device Record Key4a95c68f-9926-4cec-ab3a-00dc9168bfe6
Commercial Distribution StatusIn Commercial Distribution
Brand NameOpen Wrench
Version Model NumberARIEOW360
Catalog NumberARIEOW360
Company DUNS687388178
Company NameMegagen Implant Co. Ltd
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809931183798 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809931183798]

Moist Heat or Steam Sterilization


[08809931183798]

Moist Heat or Steam Sterilization


[08809931183798]

Moist Heat or Steam Sterilization


[08809931183798]

Moist Heat or Steam Sterilization


[08809931183798]

Moist Heat or Steam Sterilization


[08809931183798]

Moist Heat or Steam Sterilization


[08809931183798]

Moist Heat or Steam Sterilization


[08809931183798]

Moist Heat or Steam Sterilization


[08809931183798]

Moist Heat or Steam Sterilization


[08809931183798]

Moist Heat or Steam Sterilization


[08809931183798]

Moist Heat or Steam Sterilization


[08809931183798]

Moist Heat or Steam Sterilization


[08809931183798]

Moist Heat or Steam Sterilization


[08809931183798]

Moist Heat or Steam Sterilization


[08809931183798]

Moist Heat or Steam Sterilization


[08809931183798]

Moist Heat or Steam Sterilization


[08809931183798]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-20
Device Publish Date2024-03-12

Devices Manufactured by Megagen Implant Co. Ltd

08809977452049 - N22024-04-10
08809931183798 - Open Wrench2024-03-20ARi ExCon Implant System
08809931183798 - Open Wrench2024-03-20 ARi ExCon Implant System
08809822761821 - TiGEN Abutment2024-02-28 ARi ExCon Implant System
08809822761937 - ZrGEN Abutment2024-02-28 ARi ExCon Implant System
08809822762002 - ZrGEN Abutment2024-02-28 ARi ExCon Implant System
08809822762019 - TiGEN Abutment2024-02-28 ARi ExCon Implant System
08809822762101 - ZrGEN Abutment2024-02-28 ARi ExCon Implant System
08809822762125 - ZrGEN Abutment2024-02-28 ARi ExCon Implant System

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